Six Sigma Green belt professional experienced in Quality, Compliance and Regulatory for the Medical Device, Biologics, Pharmaceutical and Combination Products industries. Expertise in preparation and evaluation of Regulatory, Compliance and New Product Development Systems.
Titles Held: World-wide Manager Strategic Quality Combination Products; Quality Manager; Senior Quality Systems Consultant; Director of Regulatory/Quality Systems/Clinical Affairs; Regulatory Coordinator
- Strong Regulatory background in regards to warning letters, recalls, protocol writing, 510(k), PMAs, IDEs, PLAs/ELAs
- Skilled in Quality systems development and deployment; New product development process from R&D to Launch
- International experience working in EU, Canada, Puerto Rico and Mexico; CE Marking and device certification
- ASQ Auditor proficient in Supplier/Contract manufacturer audits
- Experienced Trainer in the areas of GMPs, cGMPs, GLPs, GCPs, QSRs, ISO 9000, 13485, Design Controls, Internal Auditor and Combination Products
CQE with twenty seven years of experience in the Medical Device and Biomedical industries. In- depth knowledge of Regulations and Standards: QSR, ISO 13485, Canadian Medial Devices Conformity Assessment System (CMDCAS), ISO 14971, 21 CFR 1270 & 1271 (Human Tissue).
Titles Held: Vice-President, Quality Assurance; Director of Quality Assurance; Divisional Quality Assurance Engineering Manager; Quality Assurance Supervisor; Production Supervisor
- Substantive experience in Design Controls, Product Development, developing Quality System documentation such as Quality Manuals, Policies, SOP’s, Risk Management, CAPA, Supplier Audits
- Exceptional understanding of failure investigations, gap analysis, auditing, FDA & ISO inspections, remediation, company acquisitions, and Due Diligence experience
- Experience in responding to the FDA on 483’s and Warning Letters
- Successfully developed several quality systems for QSR and ISO 13485 compliance
- Extensive International QA and auditing experience in Mexico, France, England, Sweden and Japan
Thirty years experience in the Pharmaceutical and high-tech Medical Device industry. Extensive knowledge of Product Development, R&D, Program Management, Quality Systems and Compliance, and Regulatory submissions.
Titles Held: Senior Vice President, Chief Scientific Officer; Principal; Senior VP Scientific Affairs; Executive Director RA/QA and Clinical Affairs; Manager, RA/QA; Senior Design Engineer
- Strong validation experience in product and process validation requirements in various countries and management of the design, implementation, and documentation of validation programs for numerous (100+) products around the world
- Experience with warning letters and consent decree situations with both domestic and international firms
- Successfully designed, developed, and certified clean room facilities in several countries and for a wide range of products
- Qualified in conducting clinical trials for IDEs and PMAs as well as clinical evaluations for market penetration purposes
- Experience with all device classes:lasers (Surgical and Ophthalmic), to implants (Orthopedic and Ophthalmic), to a wide range of electronic products, disposables, IVDs, and biologics (homologous bone grafts)
Twenty year CQA professional with experience in both Quality Systems and Regulatory Affairs. Excellent Audit, Validation, Compliance and Design Control background in the Medical Device and Pharmaceutical industries.
Titles Held: Senior Consultant; Director of Quality Assurance; Project Manager
- Excellent international experience: Created several Technical Files and Design Dossiers for the EU, packages for licensing on 6 continents including Canadian License and obtaining Japanese shonin.
- Submittal experience with INDs, IDEs, 510Ks, 510Ks with clinical, PMAs, 1 BLA, 1 HDE, CBE-30s and pre-approval supplements (PAS) for CMC changes to approved products
- QA Validation: Heavy Design Control background; QA review of Testing Protocols and Final Test Reports to assure compliance with applicable standards and regulations
- Strong audit experience with both Internal and External Audits; OEM’s, manufacturers; clinical study sites; sterilization facilities to name a few
- Exceptional Technical Writing skills as well knowledge of Regulations and Guidelines: cGMP, cGCP/ICH, cGLP, QSR, ISO 13485:2003, MDD (all Annexes), HIPAA, 21 CFR Part 11, HACCP, Canadian Regulations, ANSI/AAMI
Computer System Validation expert with twenty-five years experience in the Medical Device and Pharmaceutical regulated environment. Provide definitive compliance technical expertise for Manufacturing; Quality software, hardware and instrument related projects including acting as Subject Matter Expert on 21CFR Part 11.
Titles Held: Senior Validation Consultant; Senior Validation Engineer; Validation Lead; Senior Project Engineer/Validation Engineer; Principal Engineer; Plant Engineer
- Full Validation Life Cycle experience including developing and maintaining Computer System VMPs, Validation Plans, Validation Scripts, and preparing Validation Reports
- Start-ups to remediation projects for pharmaceutical, biotech and medical device companies; experienced in new product launches, FDA 483 Warning Letter Remediation and Consent Decree compliance
- Expert in IQ/OQ/PQ, FDA Compliance, cGMPs Audits, Complaint Reporting Systems, Bar-Code Systems, Vision Systems, PLCs, SOPs, SCADA systems and server-based systems
- Experienced in conducting compliance audits including vendor audits
- Demonstrated success in interviewing organizations to gather understanding of needs and requirements
A Medical Device professional with ten years experience in management and development of Quality and Regulatory programs. Excellent at identifying and resolving issues using systematic analysis and problem-solving skills.
Titles Held: Director of Quality Systems; Manager Quality Control; Manager QA/RA
- Managed ISO/cGMP compliance and coordinated QA/QC activities of a medical device Quality System
- Hands-on experience with Compliance; Process Improvement; Root Cause Analysis, Risk Analysis
- Process Development; Design Control of the DHF & DMR
- Upgraded and managed processes for: Complaints, Corrective and Preventive Action (CAPA), material review board (MRB), product change control (CO), Design History File & Review and supplier quality programs
- Directly involved with FTA, FMECA, DFM reviews, CE conformance reviews, and the design review; ISO 14971, FMEA and risk management plans
Nineteen years of direct hands-on experience in Class I/II/III medical devices and In-Vitro diagnostics. Extensive experience in Pharmaceutical and Biologic operations in the areas of regulatory affairs, compliance, validation and quality systems to ensure compliance with FDA and international regulations.
Titles Held: Director of FDA Regulations and Compliance; Corporate Director of Technical and Regulatory Compliance; Corporate Manager of QA/RA; Manager of Quality Engineering
- Expertise in executing process validation, remediation, supplier qualification, training, internal/due diligence audits and policy/procedure development
- Skilled in Risk Management/Assessment; ISO 9001/13485/14971; MDR/AE/product complaints and CAPA’s
- International experience in Japan, EU and Canada regulatory bodies/agencies; also MDD 93/42/EEC and CE Mark and Notified Bodies
- Experience with PMA’s, IDE’s, 510(k)’s, NDA’s and e-CTD/CMCs submissions
- Knowledge with inspection readiness for manufacturers
Thirty-five years of experience in Regulatory (FDA) Submissions, FDA and ISO Quality Systems for the Medical Device and IVD industry. Additional experience with Quality Assurance, Manufacturing, Clinical Affairs, Medical Services, Customer Services and Instrument Repair Services.
Titles Held: Vice President of Quality Assurance/Regulatory Affairs; Vice President of Clinical, Quality and Regulatory Affairs; Director of QC/QA
- Clearance and Approval of over thirty-five 510(k)’s, PMAs and BLAs
- Managed three IVD corporations to ISO 9001 and 13485 Certifications
- Developed and Commercialized 8 lVD’s (R&D)
- CE Marking, Canadian Product Registrations, experience working in Germany and Japan
- Extensive knowledge of In-Vitro Diagnostics, all classes including Biologics
Regulatory and quality systems specialist with twenty-three years of medical device experience. Excellent understanding of FDA, European, and Canadian requirements, 510(K) pre-market notifications, supplier quality management, process and software validation, risk management, project management, and statistical process control.
Titles Held: Quality Assurance Manger; Senior Process Engineer; Manager of Control Laboratory; Process Engineer
- Experience Conducting mock FDA inspections and QSR training
- Worked for Start Up companies to large medical device firms
- Managed quality systems registrations for US and European clients ISO 19385/6, CMDCAS
- Management and coordination of recalls and corrections, FDA inspections and related events
- Regulatory Affairs Certification (RAC), Certified Quality Auditor (CQA)
ASQ professional with twenty-two years of experience in regulatory compliance, project management and business process improvement. Industry experience in drugs, biologics, medical devices, IVDs, and tissue banking.
Titles Held: Director of QA/RA; Principal; Corporate Director of Quality /Regulatory; QA/RA Specialist; Project Coordinator, Manager of Clinical Services
- Proven capability to accomplish results in different countries and varied business functions
- Strong FDA applications for Biologics IND Phase O to III; FDA applications for medical devices and IVDs, IDE’s through PMA’s
- Experience with Quality programs, Design Control, SOPs, Assessments, Validation and CAPA’s
- US, EU, and CE Marking medical devices and diagnostics; EU and ISO quality management audits
- Experienced Auditor with QSR, EU, GC; prepared and received accreditation in EU GMP, QSR, ISO 13485, ISO 9001